Decision making for AIR active substances Crop Protection European Regulatory Conference 11-12 March...
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Transcript of Decision making for AIR active substances Crop Protection European Regulatory Conference 11-12 March...
Decision making for AIR active substances
Crop Protection
European Regulatory Conference11-12 March 2015, Brussels
Jeroen Meeussen
European Commission
DG SANTE (Health and Food Safety Directorate-General)
Unit Pesticides and Biocides
The AIR programmes
● AIR-1 – 7 substances – 14 MS
● AIR-2 – 31 substances – 21 MS
● AIR-3 – 150 substances – 28 MS
● AIR-4 – 223 substances – 28 MS
Current situation: AIR-1
● All decisions on Annex I Renewal (AIR-1) substances have been taken - 7 substances.
● Regulation is applicable from: 1 January 2012.
● Re-authorisation of products: 31 December 2015.
● Expiry of approval: 31 December 2021.
Current situation: AIR-2
● Regulation (AIR-2) has been published in December 2010: (EU) No 1141/2010.
● Guidance Document has been noted (SANCO/10387/2010 - rev. 8).
● 31 substances: 29 dossiers have been received; decision making is ongoing.
● Expiry of approval: 31 December 2015.
…but
● Emerging concerns about delays:
…until now only one decision on renewal of approval has been taken…
and
● Decisions apply from 1 January 2016:
… as a consequence new data requirements would apply to the re-authorisation of PPPs…
● Legal framework for AIR-3:- Regulation with the general procedure (Reg. (EU) No 844/2012);- List of RMS & Co-RMS (Reg. (EU) No 686/2012);- Guidance Document (SANCO/2012/11251- rev. 4).
● Extensions only possible if an application has been submitted.
● Strict timelines (29.5 months from dossier submission till decision).
Current situation: AIR-3
Expiry date No AS
< 14 June 201440
July 2014 – November 2015
27 (23)
February 2016 –
November 2017
55
> 31 July 2018 28
AIR-3 substances
Regulation
Reg. 823/2012
Reg. 1197/2012
Reg. 533/2013; Reg. 762/2013;Reg. 1136/2013; Reg. 85/2014;Reg. 487/2014; Reg. 678/2014;Reg. 878/2014; 2 Reg. to be published
-
Extension
until 1/2017
until 7/2017
until 7/2018
no extension
-8-
Renewal Timelines (Reg. 844/2012)
Activity- Dossier submission: - Admissibility check:- Renewal Assessment Report (RAR):- RAR circulated to MS and applicant:- Public Commenting (incl. MS & applicant):- EFSA peer-review: - Stop the clock:- COM decision:
• Time• 0• 1 month• 11 months• 1.5 months• 2 months• 5 months• 3 months• 6 months
-9-
Renewal Timelines (Reg. 844/2012)
Time needed from dossier submission to COM decision:29.5 months Available time according to Reg. 844/2012:30 months
Did we developed a workable programme???
● Legal framework same as for AIR-3:- Regulation with the general procedure (Reg. (EU) No 844/2012);- List of RMS & Co-RMS: in preparation;- Guidance Document (in principle SANCO/2012/11251 applies).
● Strict timelines (29.5 months from dossier submission till decision).
● Extensions necessary?
What about AIR-4?
Number of Active Substances: AIR-4
2019 2020 20210
20
40
60
80
100
120
140
160
63 AS14 AS146 AS
AIR-4: 2019
Batch Current expiry date Number of AS
1 28 February 2019 5
2 30 April 2019 22
3 31 July 2019 4
4 31 August 2019 87 ('list 4')
5 31 October 2019 5
6 30 November 2019 7
7 31 December 2019 16
Total 146
AIR-4: 2020
Batch Current expiry date Number of AS
1 31 March 2020 1
2 30 April 2020 1
3 31 May 2020 2
4 30 June 2020 2
5 31 July 2020 3
6 31 August 2020 1
7 31 October 2020 2
8 31 December 2020 3
Total 14
AIR-4: 2021
Batch Current expiry date Number of AS
1 31 January 2021 2
2 31 March 2021 1
3 30 April 2021 5
4 31 May 2021 35
5 31 July 2021 2
6 30 September 2021 1
7 31 December 2021 17 (7 AIR-1 AS)
Total 63
The AIR-programmes…..
…..the workload…..
-17-
This has to be stopped!
Article 82 review…
…3 months after renewal of approval of active substance!
Art. 43: Renewal of Authorisation
Renewal of Authorisation• Application (incl. dRR) 3 months after Commission
decision to renew the approval of the active substance.
• Difficult to prepare a dossier incl. risk assessments for product re-authorisation before the active substance endpoints are finalised.
• Choice of zonal rapporteurs.
• Capacity issues.
• Products containing mixtures of active substances will trigger multiple Article 43 submissions and reviews.
•
Renewal of Authorisation
Article 43(6): ‘reasons beyond the control of the authorisation holder.’
• If it is not possible for the applicant to provide studies in time due to a new endpoint.
• Applicant has to justify the lack of data.
• Member States may find it appropriate to apply Article 43(6) and delay re-authorisation of the product.
• Member States have the responsibility to ensure that appropriate protection standards are respected.
•
Increasing Article 43 workload…
• Guidance on renewal of authorisations is in preparation to assist in managing the workload!
New Data Requirements
● Apply from 1 January 2014.
● Active Substance: - for all applications submitted under Regulation 844/2012 ("AIR-3" and beyond).
● Products: - Not to AIR-1 as long as applications for re-authorisation are submitted before 31 December 2015;- What about AIR-2?- Applicable to all re-authorisations AIR-3.
● Guidance Document on transitional measures (SANCO/11509/ 2013 rev. 3).
Data Requirements - AIR-2● Active Substance:
- for all applications submitted under Regulation 1141/2010 old data requirements apply.
● Products: - current text: old data requirements apply only as long as applications for re-authorisation are submitted before 31 December 2015.
● Legislation in preparation to ensure that old data requirements continue to apply as regards re-authorisations of PPPs containing an AIR-2 substance.
● Guidance Document on transitional measures (SANCO/11509/ 2013 rev. 4 in prep.)
Conclusions
● Legal framework for renewal of approval of active substances is in place.
● Challenge to cope with the deadlines.
● Reflect on a change of the system of renewal of approval of AS and re-authorisation of PPPs
in light of Article 82 review.
● A workshop late 2015/early 2016 might be a first step.
What about the future?
Any questions?